The firm – a subsidiary of Sigma-Aldrich Corporation – is not the only company to offer biomanufactures downstream process testing services in support of viral clearance validation studies, said Mike Garrett, Senior Director, Global Marketing at BioReliance.
He told Biopharma-Reporter.com the company had the advantage over its competitors with a mixture of its “scientific knowledge, regulatory expertise, high-grade virus preparation, and now the most modern, flexible and up-to-date equipment and facilities available.”
With the new facility, he explained, clients can “set up a ‘down-scale’ version of the purification process,” challenge that process and collect “the eluate from the step being tested (either column chromatography or nanofiltration) to determine the reduction in viral load from the initial spike of the process.
“This data then allows us to work with the client to assign a log reduction of viral load (if any) to a particular purification step,” before it is submitted to the regulatory authorities.
Viral clearance is necessary for manufacturers of biologics as they are required by regulatory agencies to assess the ability of the manufacturing process to produce a safe product for human use.
The aim is to look at the manufacturing process as a whole, with each process step studied to be challenged with an appropriate preparation of high-titer test virus.
Garrett also told us Bioreliance had the capacity to offer its clearance services in-house, but “In most cases, the client travels to the BioReliance site and sets up its downstream processing step to ensure fidelity in the replication of the process from manufacturing scale.”
According to 2006 guidance from the European Medicine’s Agency (EMA), viral clearance assessments must take into consideration such factors as the nature of the production cell line, the history of the cell line and its use, the extent of characterisation of the cell line, and the use or non-use of raw materials of human and/or animal origin during manufacture.